Novo Nordisk, a global healthcare company with more than 90 years of innovation and leadership in diabetes care, has launched Ryzodeg in Mexico, the first country in the world, for people with type 2 diabetes.
Ryzodeg is a combination of two distinct insulin analogues (insulin degludec and insulin aspart in the ratio of 70% and 30%), making it the first combination of a basal insulin with an ultra-long duration of action and a well-established mealtime insulin in one pen for people with type 2 diabetes.
Ryzodeg offers adults with type 2 diabetes successful reductions in HbA1c1, with lower risk of hypoglycaemia versus biphasic insulin aspart 303. As Ryzodeg is a combination product it requires fewer daily injections than administering basal and mealtime insulin in separate injections.
"Ryzodeg is a new approach to diabetes management, and we are very pleased to make it available now for people with diabetes. Ryzodeg has documented excellent glucose control and a low risk of hypoglycaemia in clinical trials, and it represents an excellent opportunity for intensification of insulin treatment with fewer injections than other treatment options," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Type 2 diabetes is a progressive disease, which means some patients will need to eventually intensify insulin treatment by adding mealtime insulin - bolus therapy - to achieve or maintain their glycaemic targets over time. Studies have shown that more than 50% of people with type 2 diabetes on basal insulin are not achieving their glycaemic targets as measured by HbA1c.
Complications from diabetes caused by failing to keep optimal glycaemic control can be serious, and may include problems such as heart disease, stroke, blindness, kidney disease, nerve damage and premature mortality. In Mexico, where 8.7 million people live with diabetes, the number of diabetes-related deaths was 70,281 in 2013.
Novo Nordisk expects to make Ryzodeg available in additional countries around the world within the next year.
In a multinational trial, Ryzodeg (insulin degludec/insulin aspart) delivered twice daily at main meals offered a successful reduction in HbA1c, with lower risk of hypoglycaemia versus biphasic insulin aspart 30 in people with type 2 diabetes, showing a: 32% lower risk of overall confirmed hypoglycaemia: 73% lower risk of nocturnal confirmed hypoglycaemia.
In other studies no apparent differences were shown between Ryzodeg and its comparators, with respect to adverse events and standard safety parameters.
Ryzodeg has been approved in Aruba, Brazil, Chile, Costa Rica, El Salvador, the EU, Hong Kong, Iceland, India, Israel, Japan, Kazakhstan, Macedonia, Mexico, Norway, Russia, South Korea and Switzerland.
The clinical trial programmes for insulin degludec (BEGIN) and Ryzodeg (BOOST) comprise the largest in the field of insulin therapy, including more than 11,000 people. Novo Nordisk completed the phase 3a BOOST programme in 2010. This programme consisted of six randomised, controlled, treat-to-target trials in more than 30 countries. More than 2000 people were included in the development programme. The programme was designed after consultancy with regulatory agencies in Europe, Japan and USA.